ArthrodesisNCT06917235
Wrist and Carpal Arthrodeses. A 1-year Follow-up Study.
An observational study of Arthrodesis and Arthrosis, run by Vestre Viken Hospital Trust at 2 sites in Norway.
Trial summary
This study at the Orthopedic Department, Drammen Hospital, examines the effectiveness and safety of various arthrodesis procedures in the wrist and carpus to relieve chronic pain and restore functional stability. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthrodesis, Arthrosis, Wrist Osteoarthritis
- What is being tested?
- Wrist and carpal arthrodesis
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Sep 2024to 15 Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will include all patients undergoing wrist and midcarpal arthrodesis at the Orthopedic Department, regardless of the specific type of procedure. Typical candidates are individuals with advanced degenerative changes in the radiocarpal joints who have not responded to conservative treatment modalities, such as medications, physiotherapy, or orthotic support. Indications for arthrodesis include conditions such as severe osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, or significant wrist instability following trauma.
Who may be able to join
- All patients undergoing wrist or carpal arthrodesis, regardless of the specific technique.
- Advanced degenerative changes unresponsive to conservative treatment.
Who cannot join
- Patients who do not accept participation in the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway2 sites, 2 recruiting
- Recruiting
Drammen Sykehus
Drammen, 3004
Per Reidar Høiness, MD Phd, +47 975 27 911, prhoines@vestreviken.no
Inger-Sofie Killingstad, sbkili@vestreviken.no
- Recruiting
Vestre Viken HF
Drammen, 3004
Inger-Sofie Killingstad, +47 47839369, sbkili@vestreviken.no
Per Reidar Høiness, MD Phd
About this study
This study at the Orthopedic Department, Drammen Hospital, examines the effectiveness and safety of various arthrodesis procedures in the wrist and carpus to relieve chronic pain and restore functional stability. Arthrodesis, which fuses two or more bones to eliminate joint mobility, is considered as a last resort when conservative treatments do not produce the desired results. The study includes patients with advanced degenerative changes, rheumatoid arthritis, or extensive injuries. Patients assessed preoperatively and postoperatively through measurements of range of motion, grip strength, and pain using various tools such as PRWHE, QuickDASH, EQ-5D-5L and NRS. The checks include X-rays and CT to evaluate healing. The data is analyzed to identify trends and factors that influence positively outcome. The follow-up takes place after 8 weeks, 3 months and 1 year postoperatively, with a focus on pain relief and functional improvement. The data are compared before and after surgery to assess the effectiveness of the intervention efficiency. The study has been applied for approval by REK, but rejected because it was assessed as a quality control project, and applied for the Data Protection Commissioner (PVO).
The data is anonymised and stored on secure servers, with switch keys stored separately. The patients give informed consent and are insured through Norwegian Patient Injury Compensation. The study seeks to improve patient care by increasing understanding of the long-term effects of osteoarthritis, including complications and secondary osteoarthritis. The results will contribute to better clinical decisions and treatments.
Read the detailed description
Background Wrist and carpal arthrodesis is a well-established surgical intervention in orthopedic surgery, primarily aimed at alleviating chronic pain and restoring functional stability. The procedure involves the fusion of two or more wrist bones, eliminating joint mobility to reduce pain and improve hand function. It is generally considered a last-resort treatment when conservative measures such as medication, physical therapy, and orthotic support fail.
Candidates for arthrodesis typically include patients with severe degenerative changes, rheumatoid arthritis, post-traumatic arthritis, or significant wrist trauma, where pain and instability severely impair daily activities. The procedure aims to improve quality of life by enabling essential functions without the limitations imposed by unstable or arthritic joints.
Surgical success is measured primarily by pain relief and functional improvement. Outcomes depend on careful patient selection, precise surgical technique, and structured postoperative follow-up. Long-term studies and systematic evaluations are essential to refine treatment protocols and identify predictive factors for successful outcomes while mitigating complications such as infection, nonunion, and adjacent joint degeneration.
Objective This study evaluates the effectiveness and safety of various wrist and carpal arthrodesis procedures, including radioscapholunate, scaphoid-trapezium-trapezoid (STT), and four-corner arthrodesis, through systematic postoperative follow-up and patient outcome assessment.
Methods Inclusion Criteria:
- All patients undergoing wrist or carpal arthrodesis, regardless of the specific technique.
- Indications include advanced degenerative changes unresponsive to conservative treatment.
Preoperative Evaluation:
- Bilateral range-of-motion (ROM) assessment (flexion, extension, ulnar and radial deviation, supination, pronation).
- Imaging: X-ray (AP, lateral, oblique) and CT with 3D reconstruction.
- Grip strength measurement with a dynamometer.
- Pain assessment using the Numeric Rating Scale (NRS).
- Patient-reported outcome measures (PROMs): PRWHE, QuickDASH, and EQ-5D-5L.
Postoperative Follow-up:
- CT at 8 weeks to assess bone healing, with possible extension of cast duration and reassessment at 12 weeks.
- Referral to occupational therapy for rehabilitation.
- Follow-up at 3 months and 1 year, repeating preoperative assessments and X-ray evaluation for secondary osteoarthritis.
Data Collection \& Analysis:
- Pre- vs. postoperative comparisons of pain, function, and grip strength.
- Statistical analyses: t-tests, chi-square, ANOVA, Cox regression, linear and logistic regression.
- Documentation of prior wrist surgeries and indications for arthrodesis.
Sample Size \& Statistical Power: With an estimated annual inclusion of 1-5 patients and a total of 10-20 participants, statistical power is limited. The study acknowledges the risk of Type II errors due to small sample size.
Regulatory Approvals \& Ethics:
- The project was reviewed by the Regional Ethics Committee (REK) and deemed a quality control study, not requiring REK approval.
- Approval from the Data Protection Officer (PVO) in Vestre Viken is pending.
- Patients will provide informed consent, ensuring voluntary participation and data confidentiality.
Data Security \& Management:
- Anonymized data stored on a secure research server.
- Key-coded data stored separately in Medinsight.
- The study follows institutional guidelines for data protection and patient rights.
Expected Impact:
- Enhancing the understanding of wrist arthrodesis outcomes to improve clinical decision-making and patient care.
- Identifying factors that optimize surgical success and rehabilitation.
Timeline:
- Regulatory approvals: Winter/Spring 2024.
- Patient recruitment: Fall 2024.
- Inclusion period: 5 years.
- Follow-up completion: 1 year postoperatively for each patient.
- Conditions
- Arthrodesis, Arthrosis, Wrist Osteoarthritis
- Being tested
- Wrist and carpal arthrodesis
- Keywords
- Wrist arthrodesis, carpal arthrodesis, follow-up, surgery, fusion
- Medical subject headings
- Ankylosis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrist and carpal arthrodesisProcedure or surgery
All patients that fit the inclusion criteria and accept the arthrodesis surgery will be followed up over the course of 1 year. The wrist and carpal arthrodesis procedures will include radioscapholunate, scaphoid-trapezium-trapezoid (STT), and four-corner arthrodeses.
| Study group | Role | What they receive |
|---|---|---|
| Arthrodesis | All patients that fit the inclusion criteria and accept the arthrodesis surgery will be followed up over the course of 1 year. The wrist and carpal arthrodesis procedures will include radioscapholunate, scaphoid-trapezium-trapezoid (STT), and four-corner arthrodeses. Receives: Procedure: Wrist and carpal arthrodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRWHE (Patient-Rated Wrist/Hand Evaluation)
The PRWHE (Patient-Rated Wrist/Hand Evaluation) form was developed to identify the degree of pain and functional impairment of the hand and wrist. It consists of two parts, one that contains five questions that focus on pain, and one with ten questions that deal with function. The questions are answered on a numerical scale from 0 to 10, where 0 means no pain or impairment and 10 the worst pain imaginable, or inability on the part of the patient to perform a certain activity. Pain and function are weighted equally by dividing the function scores by 2, and a total sum ranging between 0 and 100 is obtained. A change of > 20 points indicates a clinically significant difference, while a change of < 10 - 12 points has little or no significance
Measured: Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.
Secondary outcomes (5)
EQ-5D-5L
EQ-5D-5L is a standardized measurement tool to assess general health status and quality of life.
It consists of five dimensions: mobility, independence, daily activities, pain/discomfort and anxiety/depression. Respondents assess their condition within each dimension. EQ-5D is used globally in health research, economic evaluations and public health planning.
The EQ VAS records the respondent's overall current health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The EQ VAS provides a quantitative measure of the patient's perception of their overall health.
Measured: Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.
Patient pain
The NRS, or Numerical Rating Scale, is a widely used method for assessing patients' experience of pain or satisfaction.
It consists of a scale from 0 to 10, where 0 represents "no pain" or "completely dissatisfied" and 10 indicates "worst imaginable pain" or "completely satisfied". Patients are asked to rate their pain or satisfaction level by selecting a number that best describes their current condition. The NRS is easy to administer and understand, and can be used in a number of medical and research contexts to quantify pain intensity or degree of satisfaction. This method is particularly useful for following changes in the patient's condition over time, as well as evaluating the effect of treatments or interventions. In assessments of pain and satisfaction, the person answers a standard question from the project staff. The NRS has been found to be both reliable and valid and is widely used when assessing pain and satisfaction.
Measured: Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.
Patient satisfaction
The NRS, or Numerical Rating Scale, is a widely used method for assessing patients' experience of pain or satisfaction. It consists of a scale from 0 to 10, where 0 represents "no pain" or "completely dissatisfied" and 10 indicates "worst imaginable pain" or "completely satisfied". Patients are asked to rate their pain or satisfaction level by selecting a number that best describes their current condition. The NRS is easy to administer and understand, and can be used in a number of medical and research contexts to quantify pain intensity or degree of satisfaction. This method is particularly useful for following changes in the patient's condition over time, as well as evaluating the effect of treatments or interventions. In assessments of pain and satisfaction, the person answers a standard question from the project staff. The NRS has been found to be both reliable and valid and is widely used when assessing pain and satisfaction.
Measured: Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.
QuickDASH
QuickDASH (the shortened version of the Disabilities of the Arm, Shoulder, and Hand questionnaire) is a tool developed to assess the level of function and symptoms in arms, shoulders and hands in people with various conditions.
It is a shortened version of the original DASH questionnaire and consists of 11 questions that focus on the physical function and symptom burden related to upper extremity musculoskeletal disorders. QuickDASH is designed to be simple and quick to administer, making it a practical tool for clinicians and researchers to measure patient health status and monitor changes over time. It can be used in a variety of settings, including clinical practice, research and population studies, and it supports treatment planning and outcome measurement for individuals with arm, shoulder and hand problems.
The total score is scaled between 0 (no disability) and 100 (maximum symptoms and disability), with an average value of 10 among the general population of the United States.
Measured: Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.
Grip strength
Grip strength is measured by means of a dynamometer. The dynamometer apparatus measures grip strength in kilograms of resistance by squeezing an adjustable (for hand size) stirrup. The higher the number of kilograms measured, the stronger the the grip strength.
Measured: Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start1 Sep 2024
- Primary completion15 Aug 2028 (estimated)
- Study completion15 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthrodesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917235
- Sponsor's protocol ID
- 24/06567-5
- Status last verified
- Apr 2025
- First submitted
- 31 Mar 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not allowed by Regional Ethics Committee according to
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wrist and Carpal Arthrodeses. A 1-year Follow-up Study.
- ClinicalTrials.gov ID
- NCT06917235
- Acronym / sponsor ID
- 24/06567-5
- Conditions
- Arthrodesis, Arthrosis, Wrist Osteoarthritis
- Keywords
- Wrist arthrodesis, carpal arthrodesis, follow-up, surgery, fusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 15 Aug 2028 (estimated)
- Study completion
- 15 Aug 2029 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study at the Orthopedic Department, Drammen Hospital, examines the effectiveness and safety of various arthrodesis procedures in the wrist and carpus to relieve chronic pain and restore functional stability. Arthrodesis, which fuses two or more bones to eliminate joint mobility, is considered as a last resort when conservative treatments do not produce the desired results. The study includes patients with advanced degenerative changes, rheumatoid arthritis, or extensive injuries. Patients assessed preoperatively and postoperatively through measurements of range of motion, grip strength, and pain using various tools such as PRWHE, QuickDASH, EQ-5D-5L and NRS. The checks include X-rays and CT to evaluate healing. The data is analyzed to identify trends and factors that influence positively outcome. The follow-up takes place after 8 weeks, 3 months and 1 year postoperatively, with a focus on pain relief and functional improvement. The data are compared before and after surgery to assess the effectiveness of the intervention efficiency. The study has been applied for approval by REK, but rejected because it was assessed as a quality control project, and applied for the Data Protection Commissioner (PVO).
The data is anonymised and stored on secure servers, with switch keys stored separately. The patients give informed consent and are insured through Norwegian Patient Injury Compensation. The study seeks to improve patient care by increasing understanding of the long-term effects of osteoarthritis, including complications and secondary osteoarthritis. The results will contribute to better clinical decisions and treatments.
Detailed description
Background Wrist and carpal arthrodesis is a well-established surgical intervention in orthopedic surgery, primarily aimed at alleviating chronic pain and restoring functional stability. The procedure involves the fusion of two or more wrist bones, eliminating joint mobility to reduce pain and improve hand function. It is generally considered a last-resort treatment when conservative measures such as medication, physical therapy, and orthotic support fail.
Candidates for arthrodesis typically include patients with severe degenerative changes, rheumatoid arthritis, post-traumatic arthritis, or significant wrist trauma, where pain and instability severely impair daily activities. The procedure aims to improve quality of life by enabling essential functions without the limitations imposed by unstable or arthritic joints.
Surgical success is measured primarily by pain relief and functional improvement. Outcomes depend on careful patient selection, precise surgical technique, and structured postoperative follow-up. Long-term studies and systematic evaluations are essential to refine treatment protocols and identify predictive factors for successful outcomes while mitigating complications such as infection, nonunion, and adjacent joint degeneration.
Objective This study evaluates the effectiveness and safety of various wrist and carpal arthrodesis procedures, including radioscapholunate, scaphoid-trapezium-trapezoid (STT), and four-corner arthrodesis, through systematic postoperative follow-up and patient outcome assessment.
Methods Inclusion Criteria:
- All patients undergoing wrist or carpal arthrodesis, regardless of the specific technique.
- Indications include advanced degenerative changes unresponsive to conservative treatment.
Preoperative Evaluation:
- Bilateral range-of-motion (ROM) assessment (flexion, extension, ulnar and radial deviation, supination, pronation).
- Imaging: X-ray (AP, lateral, oblique) and CT with 3D reconstruction.
- Grip strength measurement with a dynamometer.
- Pain assessment using the Numeric Rating Scale (NRS).
- Patient-reported outcome measures (PROMs): PRWHE, QuickDASH, and EQ-5D-5L.
Postoperative Follow-up:
- CT at 8 weeks to assess bone healing, with possible extension of cast duration and reassessment at 12 weeks.
- Referral to occupational therapy for rehabilitation.
- Follow-up at 3 months and 1 year, repeating preoperative assessments and X-ray evaluation for secondary osteoarthritis.
Data Collection \& Analysis:
- Pre- vs. postoperative comparisons of pain, function, and grip strength.
- Statistical analyses: t-tests, chi-square, ANOVA, Cox regression, linear and logistic regression.
- Documentation of prior wrist surgeries and indications for arthrodesis.
Sample Size \& Statistical Power: With an estimated annual inclusion of 1-5 patients and a total of 10-20 participants, statistical power is limited. The study acknowledges the risk of Type II errors due to small sample size.
Regulatory Approvals \& Ethics:
- The project was reviewed by the Regional Ethics Committee (REK) and deemed a quality control study, not requiring REK approval.
- Approval from the Data Protection Officer (PVO) in Vestre Viken is pending.
- Patients will provide informed consent, ensuring voluntary participation and data confidentiality.
Data Security \& Management:
- Anonymized data stored on a secure research server.
- Key-coded data stored separately in Medinsight.
- The study follows institutional guidelines for data protection and patient rights.
Expected Impact:
- Enhancing the understanding of wrist arthrodesis outcomes to improve clinical decision-making and patient care.
- Identifying factors that optimize surgical success and rehabilitation.
Timeline:
- Regulatory approvals: Winter/Spring 2024.
- Patient recruitment: Fall 2024.
- Inclusion period: 5 years.
- Follow-up completion: 1 year postoperatively for each patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arthrodesis | – | Procedure: Wrist and carpal arthrodesisAll patients that fit the inclusion criteria and accept the arthrodesis surgery will be followed up over the course of 1 year. The wrist and carpal arthrodesis procedures will include radioscapholunate, scaphoid-trapezium-trapezoid (STT), and four-corner arthrodeses. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include all patients undergoing wrist and midcarpal arthrodesis at the Orthopedic Department, regardless of the specific type of procedure. Typical candidates are individuals with advanced degenerative changes in the radiocarpal joints who have not responded to conservative treatment modalities, such as medications, physiotherapy, or orthotic support. Indications for arthrodesis include conditions such as severe osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, or significant wrist instability following trauma.
Key inclusion criteria (2 listed)
- All patients undergoing wrist or carpal arthrodesis, regardless of the specific technique.
- Advanced degenerative changes unresponsive to conservative treatment.
Key exclusion criteria (1 listed)
- Patients who do not accept participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wrist and carpal arthrodesisAll patients that fit the inclusion criteria and accept the arthrodesis surgery will be followed up over the course of 1 year. The wrist and carpal arthrodesis procedures will include radioscapholunate, scaphoid-trapezium-trapezoid (STT), and four-corner arthrodeses. | Procedure or surgery | Arthrodesis |
Primary outcome
PRWHE (Patient-Rated Wrist/Hand Evaluation)
Time frame: Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.
The PRWHE (Patient-Rated Wrist/Hand Evaluation) form was developed to identify the degree of pain and functional impairment of the hand and wrist. It consists of two parts, one that contains five questions that focus on pain, and one with ten questions that deal with function. The questions are answered on a numerical scale from 0 to 10, where 0 means no pain or impairment and 10 the worst pain imaginable, or inability on the part of the patient to perform a certain activity. Pain and function are weighted equally by dividing the function scores by 2, and a total sum ranging between 0 and 100 is obtained. A change of > 20 points indicates a clinically significant difference, while a change of < 10 - 12 points has little or no significance
5 secondary outcomes
EQ-5D-5L
Time frame: Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.
Patient pain
Time frame: Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.
Patient satisfaction
Time frame: Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.
QuickDASH
Time frame: Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.
Grip strength
Time frame: Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: No. Not allowed by Regional Ethics Committee according to
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthrodesis and Arthrosis, run by Vestre Viken Hospital Trust at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Per Reidar Høiness, MD Phd (+47 975 27 911, prhoines@vestreviken.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRWHE (Patient-Rated Wrist/Hand Evaluation) (time frame: Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.